Search results
WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval
The Sun Chronicle· 4 hours agoWestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the ...
SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
The Pilot News· 4 hours agoSN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
CNN via Yahoo News· 9 hours agoThe US Food and Drug Administration is considering a requirement for blood banks to use a new test...
FDA recalls popular diabetes care app after glitches result in injuries to 224 patients
Scripps News via AOL· 7 hours agoA glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin...
FDA urges providers to ‘transition away’ from Getinge cardiovascular life support pumps
FierceBiotech· 15 hours agoFollowing 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life...
US FDA advises healthcare facilities to switch from Getinge's heart devices
Reuters· 16 hours ago, opens new tab heart devices in patients as they faced safety and quality concerns despite a string...
JD Supra: Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files
JD Supra· 14 hours agoOn April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides ...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 4 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
The FDA misses its own deadline to propose a ban on formaldehyde from hair products
NPR· 14 hours agoThe federal agency proposed the ban in October 2023 and scheduled its implementation for April 2024....
FDA Issues Final Guidance to Clarify "Remanufacturing" of Devices that Need Maintenance or Repair
WFRV 5 Green Bay· 18 hours ago"Today's action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices," said Jeff Shuren, M.D., J.D., director ...